SymBio Pharmaceuticals Limited and Eisai Co., Ltd. Conclude License Agreement for Bendamustine Hydrochloride (SyB L-0501) in Korea and Singapore
SymBio Pharmaceuticals Limited
Eisai Co., Ltd.
SymBio Pharmaceuticals Limited (Headquarters: Tokyo, President and CEO: Fuminori Yoshida, “SymBio”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO, Haruo Naito, “Eisai”) announced today that the companies have concluded an exclusive license agreement on development and marketing for SyB L-0501 (bendamustine hydrochloride, “Bendamustine”). Under this agreement, SymBio shall grant exclusive development and marketing rights for Bendamustine to Eisai in both Korea and Singapore.
The estimated annual number of newly diagnosed patients with non-Hodgkin's lymphoma in Korea and Singapore is approximately 2300 and 300 patients, respectively. It is well-known that a large number of these patients are prone to relapse after responding to initial treatment, making further treatment difficult despite a long overall survival period.
Through this partnership, SymBio will accelerate expansion of its pharmaceutical business in Asia Pacific with Bendamustine as its first product in the region. Eisai, for its part, will work to begin its full-scale business deployment in the oncology area in Asia, including Korea and Singapore, with the addition of Bendamustine to its extensive in-house anticancer pipeline of products.
Bendamustine has been on the market in Germany for a number of years where it has been approved for use in non-Hodgkin's lymphoma, multiple myeloma, and chronic lymphocytic leukemia. Bendamustine is being marketed in the United States as well after the US FDA (Food and Drug Administration) approved for the treatment of chronic lymphocytic leukemia in March 2008 and the treatment of patients with relapsed indolent B-cell non-Hodgkin's lymphoma in October of the same year. In Japan, SymBio has completed its Phase II study for indolent non-Hodgkin's lymphoma and Mantle cell lymphoma, with confirmation by an Independent Review Meeting that all the cases were “evaluable” in March of this year. SymBio and Eisai are currently advancing preparation towards the filing of the NDA for Bendamustine with the Japanese regulatory authorities by the end of fiscal year 2009.
In a collaborative effort to address unmet medical needs, SymBio and Eisai will work in tandem to expedite the development of Bendamustine so that it will be available for use by patients and healthcare professionals in Korea and Singapore as early as possible.
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